Pharmaceutical Quality GMP Auditors (Consulting)
如果你还不是我们网络的一部分，请使用专家注册表格进行注册。注册是需要考虑的。如果你在我们的网络中，不要填写这个表格或点击链接。位置 这个职位可以访问日本本地候选人。公司信息 在 Advarra,我们寻求促进一个包容和协作环境，每个人都受到尊重，并接受不同的观点。对待彼此，客户和临床试验参与者有同情心和关怀是 Advarra 的文化的主要原则；我们致力于创造一个工作场所，每个人不仅被重视，而且能够壮成长和产生意义的影响。公司文化 我们的人员 - - 员工和顾问是 Advarra 的核心。他们是我们的成功的关键，也是我们使命和愿景背后的驱动力。我们的价值观 （患者中心，道德，质量专注，协作）指导我们的行动和决策。知道我们的工作对试验参与者和病人的影响，我们采取紧急措施推进临床研究，以便人们能够更快乐，更健康的生活。工作总结 Advarra 正在寻求良好的制造实践网站 (GMP) 审计人员加入日本为本地项目咨询网络。审计师支持 GCP 临床和供应商之间的合规审查。· 进行良好的制造实践 (GMP) 审计 （规划，议程，物理或远程审核和报告编写）·评估调查人员的网站，CRO 以及供应商合规或资格。·准备详细说明发现和根本原因的综合审计报告。· 在英语中提供书面审计报告；· 如有必要，将为 QA 领导层和利益相关者提供纠正行动支持并向其提出结果。·与客户合作确保质量标准。基本资格。•至少10年以上临床质量保证和/或良好的制品实践 ( GMP) 的经验。·最低5年以上良好的制造成实践 (gMP) 的审计经验。· 经验证明与监管机构的期望 （例如 FDA,EMA）和审计准备活动。· 在制定和实施质量保证计划，审计方案和纠正行动计划方面有经验证明。· 英语沟通，口头写作水平 B2级；日本语沟通语言和书面水平 B2学位优先资格
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Location
This role is open to candidates based in Japan.
Company Information
At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.
Company Culture
Our people--both employees and consultants—are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.
Job Overview Summary
Advarra is seeking Good Manufacturing Practice (GMP) Auditors to join our consultant network for Japan-based projects. Auditors support compliance reviews across GCP clinical sites and vendors.
Job Duties & Responsibilities
- Conduct Good Manufacturing Practice (GMP) audits (planning, agenda, physical or remote audit, and report writing)
- Evaluate investigator sites, CROs, and vendor compliance or qualification.
- Prepare comprehensive audit reports detailing findings and root-causes.
- Provide written audit reports in English.
- If required will provide corrective actions support and present findings to QA leadership and stakeholders
- Work collaboratively with clients to ensure quality standards.
Basic Qualifications
- Minimum 10+ years of Clinical Quality Assurance and/or Good Manufacturing Practice (GMP) experience.
- Minimum 5+ years of Good Manufacturing Practice (GMP) auditing experience.
- Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
- Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
- B2 level in English communication, verbal and written
- B2 level in Japanese communication, verbal and written
- Bachelor's degree
Preferred Qualifications
- Strong interpersonal and client interaction skills.
- Excellent analytical, problem-solving, communication, and report-writing skills.
- Ability to work collaboratively across departments and interact with internal and external stakeholders.
Originally posted on Himalayas